MEND Repair & Recover Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
Study Overview
Brief Summary
This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.
Detailed Description
This study consists of 7 study visits that occur over 6 months after operative fixation of femoral fragility fracture. Consenting participants will be asked to complete the study assessments/procedures at the time points described below. Patients will be treated with operative fixation of their fracture per standard of care.
Preoperative
- Mini-Mental State Examination (MMSE-2®): This is a screening tool for cognitive impairment and will be used to determine eligibility for the study.
- Subjects will be randomized to the intervention arm or control arm in a 1:1 ratio. Subjects randomized to the control arm will receive standard of care nutrition during hospital admission. Subjects randomized to intervention arm of this study will receive essential amino acid (EAA)-based oral nutrition supplementation in addition to standard of care nutrition. Subjects will take the supplement twice daily for 4 weeks after injury. Supplementation will begin within 72 hours of surgical fixation.
Day of Surgery (DOS):
- Muscle Biopsy: Bilaterial biopsies will be obtained from the superficial vastus lateralis muscle on the injury extremity. Biopsies will be performed by board-certified orthopedic surgeons.
- Systemic Inflammatory Labs: A sample of about 15 mL of peripheral venous blood will be obtained by trained clinical staff.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospital inpatient
- •Age ≥ 65 years old on admission
- •Low-energy mechanism of injury
- •Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
- •Indicated for surgical fixation
- •Able to provide informed consent
Exclusion Criteria
- •Part of a vulnerable population (ex: Incarcerated, Non-English speaking)
- •Cognitive impairment (MMSE score ≤ 17)
- •Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)
- •Non-ambulatory prior to injury
- •Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)
- •Concern for inability to complete follow-up
- •Hemi or total arthroplasty (joint replacement)
- •Patients with a historical diagnosis of chronic kidney disease (CKD)
Arms & Interventions
Essential Amino Acid Supplementation
Subjects randomized to intervention arm of this study will receive essential amino acid (EAA)-based oral nutrition supplementation in addition to standard of care postoperative nutrition. Subjects will take 1 scoop (26.7g) of supplement twice daily for 4 weeks after injury. Supplementation will begin within 72 hours of surgical fixation. The EAA-based supplement used in this clinical trial is MEND™ Repair and Recover®.
Intervention: Essential Amino Acid Supplementation (Combination Product)
Standard of Care Postoperative Nutrition
Subjects randomized to the control arm of this study will receive no intervention. They will receive standard of care postoperative nutrition.
Outcomes
Primary Outcomes
Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
Time Frame: Day of Surgery, 3 weeks
Biopsy results will provide the counts and averages by Type I and Type II fibers for satellite cells, myonuclei, M1 and M2 macrophages.
Concentration of c-terminal agrin fragments
Time Frame: Day of Surgery, 3 weeks
Through serum analysis levels of c-terminal agrin fragment will be measured in ng/mL.
Cross sectional concentration of Type 1 and Type 2 muscle fibers
Time Frame: Day of Surgery, 3 weeks
Biopsy results will provide the Type I and Type II muscle fiber cross sectional area in µm2.
Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha
Time Frame: Day of Surgery, 3 weeks
Through serum analysis levels of myostatin, interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α) will be measured in pg/mL.
Secondary Outcomes
- Change in skeletal muscle(Postoperative day 1, 3 weeks, 6 weeks, 12 weeks)
- Measurement of self-reported physical capability(Post operative day 1, 3 weeks, 6 weeks, 12 weeks, 6 months)
- Measurement of self-reported ability to complete activities of daily living (ADL)(Preoperative, 3 weeks, 6 weeks, 6 months)
- Measurement of lower extremity functioning in older adults(12 weeks)
- Assessment of mobility, balance, walking ability, and fall risk in older adults(12 weeks)
- Assessment of independent or communal living(Preoperative, 3 weeks, 6 weeks12 weeks, 6 months)
Investigators
Michael C Willey
Assistant Professor
University of Iowa